Last Updated Jan 18, 2010 10:36 AM EST
In late April 2009, Sequenom announced an internal investigation into the data it was using in its development of a test for Down Syndrome. In September, it revealed that data was "inadequately substantiated" and that work would begin again. The CEO and six other execs were kicked out. The company is currently under investigation by the SEC and the FBI. One of the departing execs was sued for alleged insider trading prior to the release of bad news. Sequenom was No. 2 among BNET's Worst Drug Companies of 2009.
That's pretty much all we know about Sequenom's problems. The company has not offered a detailed account of the findings of its internal investigations. But last week's settlement contains several specific provisions that appear to be aimed at fixing pieces of Sequenom that must have been broken until now.
The changes can be broken into three types: Those related to internal transparency and accountability; those related to R&D; and those affecting director-level corporate governance.
The transparency/accountability changes:
- Sequenom's reporting structure has been reformed, "reducing the number of direct reports to the Company's Chief Executive Officer."
- The company's "Open Door Committee" will now take all complaints by employees, not just financial ones.
- A new "Disclosure Committee" will be "responsible for testing the reliability of information to be disclosed to the public."
The R&D changes:
- A new "Scientific Review Committee" will oversee Sequenom's R&D.
- A full-time biostatistician and an external consultant clinical biostatistician have been hired.
- A new set of standard operating procedures regarding study design planning and review, has been introduced, "including clear identification of whether a study is blinded or unblinded, raw data storage at multiple locations, independent third-party review of blinded clinical data, and a redundancy review of clinical study design by the Oversight Committee and of blinded clinical data by the Scientific Review Committee, the clinical group and the Company's biostatistician."
- And, "The Company has revamped its policy concerning the storage of clinical samples, including requiring that samples be stored in third-party storage facilities, bar-coding samples for electronic tracking and auditing, creating formal procedures for obtaining a sample, and limiting access to the Company's sample storage freezer."
The corporate governance changes:
- A majority of the board of directors must be "independent."
- Independent directors may serve on no more than four other company boards.
- 50 percent of independent directors' fees shall be delivered in stock.
- All directors must actually attend the annual general meeting
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